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The Tennessean

Sen. Ferrell Haile

Rep. David Shepard

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Legislators have narrowed the scope of a bill that would have removed Tennessee’s patient-specific requirement for mixing medicines — a safeguard that compounding pharmacies violated and the state did not actively enforce.

A new amendment to the bill would allow health care providers to buy compounded medicines without individual prescriptions whenever a drug product is not commercially available. Persistent drug shortages are the reason this loophole is needed, according to Baeteena Black, executive director of the Tennessee Pharmacists Association, and the two legislator-pharmacists who are sponsors of the legislation, Sen. Ferrell Haile and Rep. David Shepard.

“How many lives are you going to lose because you don’t have medication?” Haile said.

If Tennessee had enforced the patient-specific requirement, hospitals would have had a much harder time securing medicines that have been in short supply, such as propofol for patients on ventilators and intravenous calcium supplements for premature babies, Black said.

“It would have been a crisis,” she said. “There’s not enough to go around. Some patients would have to do without. They would have to try alternative drugs that might not be the drug of choice.”

New England Compounding Center, the company whose medicine has been blamed for the nationwide meningitis outbreak that has killed 51 and sickened 730 with fungal infections, was licensed to mix patient-specific drugs but actually did large-scale manufacturing. This was just one of several violations by the company, Black said.

While the Tennessee Pharmacists Association is seeking to weaken one provision of the state law that establishes safety guidelines, it is not advocating any stricter requirements such as accreditation. Quality issues are covered by updated requirements that the Tennessee Board of Pharmacy, the state regulatory authority over compounding labs, is considering, Black said.

“Accreditation is still optional,” she said. “It’s optional across the country. A lot of the accreditations have to do with policies, documentation. We do have a few pharmacies that are accredited — but you have to understand that’s a very lengthy and expensive process.”

Haile said the Tennessee board should set quality guidelines, not an outside accrediting agency.

The amendment would allow medicines in short supply to be provided by any pharmacy in the United States licensed in Tennessee.

Although both he and Shepard are pharmacists, Haile said they have nothing to gain from the legislation.

“This is not about David’s practice,” Haile said. “I don’t even own a pharmacy anymore. I’m not certified to do this type of practice, so this is not about individual practice. This is about public health and how we take care of patients.”

The legislation, Senate Bill 582 and House Bill 317, is up for discussion this week before the Senate Health and Welfare Committee.